Sterile Disposable Contour Cuff
This cuff and protective sleeve is a sterile, single use product. This part number is a 30 inch model with single port and single bladder.
21manufacturers in China registered for this device type
20catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (8), Guangdong (8), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Zhejiang Longyou Landmedical Technology Co., Ltd. | Longyou | Zhejiang | Contract manufacturer | 7 |
| Tiantai Shengtengyun Medical Supplies Co., Ltd. | Tiantai County | Zhejiang | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
Showing 12 of 21. All 21 manufacturers in China registered for Tourniquet, Pneumatic
Record
| Listed by | Delfi Medical Innovations Inc., Canada |
|---|---|
| FDA product code | KCY |
| Device type | Tourniquet, Pneumatic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5910 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60-7970-153-00 | In distribution | |
| 60-7975-155-00 | In distribution | |
| 60-7975-105-00 | In distribution | |
| 60-7970-154-00 | In distribution | |
| 60-7970-106-00 | In distribution | |
| 60-7975-154-00 | In distribution | |
| 60-7975-106-00 | In distribution | |
| 60-7975-103-00 | In distribution | |
| 60-7970-104-00 | In distribution | |
| 60-7970-156-00 | In distribution | |
| 60-7970-155-00 | In distribution | |
| 60-7970-107-00 | In distribution | |
| 60-7970-157-00 | In distribution | |
| 60-7975-156-00 | In distribution | |
| 60-7975-107-00 | In distribution | |
| 60-7975-153-00 | In distribution | |
| 60-7975-157-00 | In distribution | |
| 60-7975-104-00 | In distribution | |
| 60-7970-103-00 | In distribution | |
| 60-7970-105-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 128 |
| Tourniquet, Pneumatic | Stryker Sustainability Solutions | 126 |
| Tourniquet, Pneumatic | VBM Medizintechnik Gmbh | 120 |
| Zimmer | Provision | 104 |
| Tourniquet, Pneumatic | Zimmer Orthopaedic Surgical Products | 91 |
| Color Cuff | Stryker GmbH | 87 |
| Stryker | Provision | 57 |
| Disposable Tourniquet Cuff | Zhejiang Longyou Lande Medical Technology Co., Ltd. | 45 |
| Zimmer Tourniquet | Renu Medical, Inc. | 42 |
| DTS-3000 | Daesung Maref Co., Ltd. | 42 |
| ExpressAire | Provision | 40 |
| Orantech | Orantech Inc. | 35 |
Showing 12 of 94. All products under Tourniquet, Pneumatic
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-04-03 | Class II | Process control | Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. | 24 units | 2022-07-22 |
| 2019-04-03 | Class II | Process control | Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. | 59 units | 2022-07-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.